7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone

EC Number:

233-566-4

EC Name:

7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone

Cas Number:

10236-47-2

Molecular formula:

C27H32O14

IUPAC Name:

7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone

Test material form:

solid

Specific details on test material used for the study:

Obtained by extraction from natural ingredients (citrus peel).
Analytical methods: GLC pattern

Test animals

Species:

mouse

Strain:

ICR

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5-6 weeks old.
- Fasting period before study: 8h prior to dosing.
- Housing: polycarbonate cages.
- Food (Hwahan pellet feed) and water ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.8 ± 1.9ºC
- Humidity (%): 72,3 ± 7.2%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 9h light /15h dark.

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

propylene glycol

Details on exposure:

Concentration up to 20% (w/v) in propylene glycol.

Doses:

2570, 1977, 1521, 1170, and 900 mg/kg.

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Examinations:
- General clinical observations and body weight, weekly.
- Gross necropsy.
- Hematology: 24 hours after treatment, the animals were anesthetized with urethane. Blood was collected as part of the procedure, centrifuged (5 min at 3000 rpm), and serum separated. Parameters measured: total protein creatinine, GPT, phosphorus, calcium, blood urea nitrogen (BUN), GOT, alkaline phosphatase, and albumin.
- Histopathology.

Statistics:

Statistical analysis method of Litchfield and Wilcoxon was used (Litchfield et al., 1949).

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 650 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 375 - <= 1 980

Remarks on result:

other: intraperitoneal.

Mortality:

The amount of dead animals after the administration of the test item was dose-related: at 2570 mg/kg, all animals died; at 1977 mg/kg, 6/10 animals died; at 1521 mg/kg, 4/10 animals died; at 1170 mg/kg, 2/10 animals died; and at 900 mg/kg, no mortality was observed.

Clinical signs:

No effects.

Body weight:

No effects.

Gross pathology:

No effects.

Other findings:

Hematology: no statistically significant differences were observed.
Histopathology: no statistically significant differences were observed.

Any other information on results incl. tables

Table 1. 50% lethal dose.

Dose (mg / kg)	1	2	3	4	5	6	7	Mortality	LD50(mg/kg) (Confidence limit)
2570	9	1	0	0	0	0	0	10/10	1,650
1977	6	0	0	0	0	0	0	6/10	(1375-1980)
1521	2	2	0	0	0	0	0	4/10
1170	2	0	0	0	0	0	0	2/10
900	0	0	0	0	0	0	0	0/10
(P=0.05 )

 

Table 2. Haematological examination.

Dose (mg/kg)	Total Protein (g/dl)	Crea­ tinine (mg/dl)	GOT(IU/Z)	Phosphorus (mg/dl)	Calcium (mg/dl)	BUN (mg/dl)	GPT (IU/l)	alkaline phosphatase (IU/Z)	Albumin (g/dl)
Control	5.27	0.93	74.8	11.6	10.2	30.2	15.6	117.6	2.92
	± 0.23	± 0.05	± 22.2	± 0.9	± 0.9	± 8.6	± 2.7	± 12.2	± 0.83
50	5.30	0.89	70.6	11.9	1111.0	32.6	18.5	111.4	2.93
	± 0.20	± 0.10	± 26.2	± 1.0	± 1.0	± 8.2	± 8.2	± 16.2	± 0.42
100	5.34	0.92	77.4	12.2	10.4	30.5	15.5	104.6	2.92
	± 0. 31	± 0.09	± 25.6	± 1.2	± 0.6	± 5.5	± 7.3	± 20.7	± 0.52

 

Applicant's summary and conclusion

Conclusions:

The LD50 of the test item in mice by ip administration was found to be 1650 mg/kg bw.

Executive summary:

To determine the acute intraperitoneal toxicity of the test item in mice, the test item was administered intraperitoneally at doses of 2570, 1977, 1521, 1170, and 900 mg/kg test item to 5 ICR mice. The LD50 of the test item in mice by ip administration was found to be 1650 mg/kg bw.